BioPharmaceutical Business Intelligence

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Serving leading biopharmaceutical companies globally:

Farmers Insurance
AstraZeneca
McKinsey
Medtronic
Colorcon
Julphar
Fish and Richardson
UBS
Novartis
Merck

Generated: January 20, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 091156

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NDA 091156 describes THEOPHYLLINE, which is a drug marketed by Cent Pharms, Hospira, Inwood Labs, Sandoz, Kv Pharm, Scherer Rp, Alpharma Us Pharms, Cenci, Chartwell Rx, Halsey, Pharm Assoc, Precision Dose, Roxane, Taro, Wockhardt, Silarx, Tris Pharma Inc, Able, Alembic Pharms Ltd, Glenmark Generics, Mylan Ireland Ltd, Pliva, Rhodes Pharms, Teva Pharms, B Braun, Baxter Hlthcare, and Hospira Inc, and is included in forty-four NDAs. It is available from twenty-two suppliers. Additional details are available on the THEOPHYLLINE profile page.

The generic ingredient in THEOPHYLLINE is theophylline. There are thirty-six drug master file entries for this compound. Twenty-seven suppliers are listed for this compound. Additional details are available on the theophylline profile page.
Summary for 091156
Tradename:THEOPHYLLINE
Applicant:Silarx
Ingredient:theophylline
Patents:0
Therapeutic Class:Respiratory Tract Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 091156
Ingredient-typeXanthines
Suppliers and Packaging for NDA: 091156
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
THEOPHYLLINE theophylline SOLUTION;ORAL 091156 ANDA Marlex Pharmaceuticals Inc 10135-604 10135-604-08 473 mL in 1 BOTTLE, PLASTIC (10135-604-08)
THEOPHYLLINE theophylline SOLUTION;ORAL 091156 ANDA Silarx Pharmaceuticals, Inc 54838-556 54838-556-80 473 mL in 1 BOTTLE, PLASTIC (54838-556-80)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;ORALStrength80MG/15ML
Approval Date:Apr 13, 2011TE:AARLD:No

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Serving leading biopharmaceutical companies globally:

Daiichi Sankyo
Chinese Patent Office
Cantor Fitzgerald
US Army
Federal Trade Commission
Chubb
Baxter
AstraZeneca
McKinsey

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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